THERAKOS CELLEX Photopheresis Procedural Kit
FDA premarket approval P860003/S092 · decided 2017-08-17
Approval details
- PMA number
- P860003
- Supplement
- S092
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAKOS CELLEX Photopheresis Procedural Kit
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2017-06-12
- Decision date
- 2017-08-17
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval for a design change to the pressure dome assembly.
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